Preservative efficacy testing: considerations and areas for savings

By Joseph Heinzelmann

Often one of the first questions we receive about the BioLumix system is “how much does it cost?” While this blog post won’t be able to cover specifics on the costs of the BioLumix system or the individual tests, it will outline some of the considerations and areas for savings as it relates to preservative efficacy testing according to the United States Pharmacopeia <51>.  In our example analysis, we are able to reduce the cost of doing PET by nearly 40%.

USP <51> helps show the effectiveness of a preservative, or a preservative system. This testing is done according to the procedures outlined in USP Chapter <51> Antimicrobial Effectiveness Testing. This chapter describes in detail which organisms to use, the appropriate inoculum based on a product, and the necessary log reductions that the preservative system needs to achieve.

Before getting started on a comparison of protocols, we have to make sure a suitability study has been performed. The following link describes how suitability can be performed: http://www.mybiolumix.com/the-importance-of-suitability-testing/. The experts at Neogen can help you with your suitability testing questions.

Before a side-by-side comparison is done, a validation is required of any alternative method. Using the protocol outlines in USP chapter <1223> Validation of Alternative Microbiological Methods we can see that the BioLumix system meets the following requirements: Specificity, Limit of detection, precision and repeatability, robustness ruggedness, false negative rate, and false positive rate. A more in-depth discussion around USP validations and Neogen’s Validation book can be found here: http://www.mybiolumix.com/biolumix-validation-book-for-dietary-supplements/

An overview of USP <51> can be found here: http://www.mybiolumix.com/guidelines-simplified-automated-microbiology-testing-system. The two methods can be broken down into two approaches; materials and labor. Comparing the materials is straight forward. Reviewing the protocol shows that each time point requires an analysis of 3 bacteria, 1 yeast and 1 mold. Each organism requires a neutralization, and multiple dilutions when using traditional microbiology. Each organism also requires a total of 5 plates! Each plate requires a dilution blank, as well as a pipette tip.


There are several points of parity between the USP <51> traditional plate count methodology and the BioLumix system. First, the BioLumix system also requires 3 bacteria, 1 yeast, and 1 mold to comply with USP <51>. Each method will also test the preservative system at multiple time points over the course of 28 days. However, the BioLumix system is able to provide a microbiological count without 5 plates, without multiple dilution blanks, and without multiple pipette tips. The picture below helps illustrate how a nearly 40% reduction is achieved with Neogen’s BioLumix system methodology.

The second comparison is to determine the amount of labor required to run a USP <51> protocol with traditional methods. With the automation of the BioLumix system eliminates plate reading. The vials in the BioLumix system are automatically read, and the result is recorded in the database. Report writing is simplified with the Certificate of Analysis generated automatically. Time study estimates performed by Neogen estimate the labor reduction using BioLumix for PET is greater than 60%!

The BioLumix system is great for additional quality testing according to USP chapters 61 and 62. The advantages of BioLumix for this application has been covered in a recent blog post: http://www.mybiolumix.com/the-relevance-of-usp-methodology-in-microbiology-in-pharmaceuticals/.

Learn more by asking our experts for a cost breakdown, suitability analysis or additional information by contacting the author or our microbiology experts.

 

Join Neogen at Ingredient Marketplace 2015

By Joe Heinzelmann

Join Neogen at booth #528 from April 7th – 9th for Ingredient Marketplace 2015 at the Orlando World Center Marriott.

Ingredient Marketplace brings together experts in the community of nutrition,
health, food and beauty products and provides opportunities for networking, purchasing and business development. Additional insights from educational programs include global insights, and categorical trends.

Neogen is a world leader in food safety, and excited to showcase new solutions to facilitate cGMPs, quality assurance programs, and verification systems at Ingredient Marketplace. Neogen will be presenting new, key products that have been validated specifically for nutritional, health food, beauty and other related products and include the BioLumix System, allergen control tests and plans, as well as hygiene monitoring equipment.

The BioLumix Rapid Microbiology System saves time, reduces staff involvement, and leads to faster product release. The validated BioLumix system also allows for easy compliance with cGMP, streamlining your microbiological testing and once again saving you time, labor and money. BioLumix delivers shorter sample preparation, automated real-time communication, fast product release and early warning of contamination. The system is also paperless and efficient, saving on disposables, time and space, while eliminating product interference, and delivering accurate results.

The BioLumix system is also fully automated, validated against USP
methodology
and supports 21 CFR Part 11 Compliant. The system delivers complete microbiology testing results within 24-48 hours, allowing for faster product release time and shorter sample prep time.

In addition, Neogen’s allergen testing solutions help companies put together best practices for allergen control. Neogen’s industry supported Supplier verification document starts with raw materials. Using testing and best practices, companies can have confidence that ingredients, sanitation teams and their products all comply with allergen label claims.

Please also visit Neogen at booth #528 to hear more about AccuPoint Advanced, Neogen’s newest and most complete hygiene monitoring system and to see a demonstration as to why the AccuPoint Advance is the right tool for the job.

Year-end wrap up: Rapid microbiology in 2014

By Gerry Broski and Ruth Eden

To those people who still honor the tradition of sending out hard copy holiday cards, it has become quite popular for families to include a “year in review update,” which updates children’s ages, significant family events and, for those that are retired, travel destinations which have been checked off the bucket list. Electronically, this is our company update and we’ll send out the electronic holiday cards later this month.

As the year comes to a close and we review input from our customers, our market data indicates that in test method evaluation our customers are looking for higher specificity, faster time to results, and a reasonable cost-per test. They also want flexibility so that the testing platform can adapt to a number of matrices. Other factors include ease of use, robustness, and a test that is approved or can be approved. These factors above must be compelling enough for a company to switch from their existing method and adopt new technology, and it’s not just the QC or QA staff who are in the evaluation loop.

I recently went on a sales call to a company which was evaluating one of our rapid micro systems for the detection of spoilage organisms, and the conversation between the QA manager and the plant manager was enlightening. While the test would involve more work and cost for the QA department, the direct benefit would be realized for the plant manager since the product could be shipped with a much shorter quarantine period, resulting in increased throughput, and significant cost saving by compressing the sales cycle.  Summary:  Cost for QA, benefit for Operations.

That being said, automated rapid detection of microorganisms is a proven process which meets the customer criteria on several levels. It is sensitive and rapid, it can be used on almost all matrices, it involves less touch-time, takes up less space than plating or film methods, and offers a good value on a cost-per test basis. When one considers that it is essentially a “load and leave” test when interfaced to a LIMS system, the benefits are clear.

Suren Zatikyan from Wepackitall commented “When we discovered the BioLumix system, we found it gave us the opportunity to generate results in a very short period of time.  In addition, validation studies that were performed by BioLumix and later confirmed by us, proved that the system is compatible with the standard methods used by USP and other standard methods developed for microbiology labs. We use the BioLumix system to perform some of our environmental testing and monitoring programs, which is very helpful to us.”

Kristopher Flores from Wepackitall added “If the BioLumix system wasn’t in place, it would be tougher to support our needs for testing and throughput. In some instances, based on our testing and our customers’ testing, we’ve been able to validate our processes in-house and eliminate third party validation. That saves time, money, and makes an impact on the big picture for our customers.”

Neogen now offers two platforms for rapid micro detection of spoilage organisms, the BioLumix System and the Soleris System.  The BioLumix system is geared toward applications which follow USP protocols including dietary supplements, cosmetics and toiletry, while the Soleris System facilitates testing in food matrices requiring AOAC approved methods.

With hundreds of BioLumix and Soleris systems in use, Neogen is the clear leader in rapid microbiology testing in dietary supplements and nutraceutical products and very strong in many market segments in the food industry with Soleris AOAC approved tests. From initial contact to the completion of the installation and beyond, our commitment is to provide unparalleled support and total customer satisfaction.

Other advantages include:

 you can count on our sales teams to respond quickly, with the focus on your needs and goals. In addition, we can quickly and easily show you the value and the ROI.

• Expertise 
– Knowing how the BioLumix or Soleris systems will work with your products gives you peace of mind. That’s why we test samples – your samples – for you.

• Compliance validation for BioLumix systems
 – If you are concerned about validation, here is more good news.  We provide complete SOPs along with a customized validation book which includes Installation Qualification (IQ), Operations Qualification (OQ) and Performance Qualification (PQ).

• Simplicity and Ease-of-Use 
– These easy to master systems offers a new level of productivity. Sample preparation takes less than 2 minutes. The BioLumix System offers certificate of analysis generation in as little as 24-48 hours.• Support – We are committed to satisfying our customers and providing unparalleled support.

The future looks bright for Neogen and the field of rapid microbiology as we continue our ongoing commitment to the evolution to our BioLumix and Soleris platforms based on customer feedback and technology gains. That being said, I would like to take this opportunity to express my appreciation to all of our valued customers with whom we have grown significantly with through the years. With your support will continue to evolve and offer you even more valuable products.

 

Automated Microbiology Testing is the Key to Laboratory Growth in the 21st Century

Modern microbiology laboratories demand efficiency, and that means constantly improving data quality and lab productivity while simultaneously shortening time to results, and lowering the manufacturing cycle. This works by lowering the required working capital investment through faster release of inventory. As microbiologists become swamped with higher and higher volumes of work, traditional paper-intensive manual plate methodologies are becoming a thing of the past, and automated technology now holds the key to future growth. 

Manual systems are tedious and labor intensive; they are susceptible to transcription errors, and require skilled lab technicians to spend excessive amounts of time performing simple, monotonous tasks. Twenty years ago, when automated microbiological testing systems were not available, this elongated time to results and plodding flow of information was a necessary evil; with the rapidity of technological advancement in the 21st century, this is no longer the case. Automated microbiological testing systems are equipped with flexible electronic designs, allowing lab personnel to more efficiently manage, review, store, and report the high volume of analytical information needed for microbiology quality assurance. Repetition of the same task again and again is often the source of inconsistent results, but automation significantly reduces the chances of human error as well as the risk of lost data, resulting in huge productivity gains for manufacturers and laboratories. In this way, automation can provide companies with a higher level of quality assurance while requiring far less labor, and this equates to a greater profit margin.

In today’s economic climate, automation is essential in order to streamline workflows and ensure a quality product. Expedition of lab work through automation is changing the way that modern microbiology labs function, and the companies that utilize these new microbiology instruments are becoming more productive than ever before. The BioLumix system brings automation to current microbiological testing, providing a new generation of microbiology labs with the tools they need to excel and overcome their challenges. The system operates by using optical sensors, which detect color and fluorescent changes in ready to use carbon dioxide sensing vials, eliminating the need to make, prepare, or quality control traditional media. Automated sample tracking and data management also allows for the safe and immediate transfer of information in a paperless format.

With many labs bereft of a large number of qualified technicians, and subject to a great deal of pressure to analyze a higher volume of samples and deliver rapid results, the BioLumix automated microbiological testing system does the tedious work for you, and can be easily operated by a non-microbiologist. All in all, this equates to a 60% savings in labor, and this newfound time can be utilized by laboratory personnel to perform higher value tasks, such as the interpretation of results and diagnoses of potential problems as early as possible. We have all heard the old adage “time is money,” and that is where the BioLumix rapid testing system truly shines. Simply put, faster detection of microbial contamination results in faster corrective action, and that saves money. A nominal investment in an automated testing system will save your lab valuable days in their quality control process, and can reduce time to results from 7-10 days to 1-2 days. If contaminants are found, products can be recalled much earlier, and manufacturers can quickly take action to substitute raw materials that do not meet specifications. They can also resume production of a high quality product much earlier, which means that a single incident of faster intervention can save more than the cost of an automated rapid testing system.  Speeding up microbiology testing results in the speeding up of production and the reduction of inventory. By implementing a rapid micro method, you can re-allocate new found floor space to increase manufacturing capacity, add more SKU’s to inventory, or reduce distribution center costs.

The BioLumix automated microbiology testing system is easy to use, and can be utilized by modern laboratories to ensure quality products, speed up production, reduce labor, and increase manufacturing capacity by enabling a rapid release of inventory. With a lower working capital investment, and a more efficacious use of microbiologists’ skills, automating with BioLumix will have a profound affect on any organization’s key profit drivers, and may very well be the key to their growth in the 21st century marketplace.

Biolumix Automation Drives Profits

BioLumix Automation Drives Profits!

No longer look at micro testing of raw materials and finished products as a “necessary evil” in remaining cGMP compliant.   Rather, with BioLumix Rapid, Automated Microbiology, you can view microbiology product testing as a position of company strength and competitive advantage!

TIME IS MONEY. . .  we have detailed financial models prepared by our current customers that demonstrate the dramatic impact BioLumix is having when you apply Multiple Days Saved to real profit drivers, such as:  

Biolumix System

  •   Savings as a result of early detection of contamination
  •   Lower cost of inventory
  •   Increase capacity of existing factory and lab
  •   Reduce cost of storage
  •   Lower cost of test related overhead
  •   Savings on cost of capital
  •   Potential improvement in account receivables. . .  all of which directly impact profits!

Automation Drives Profits
The enacted cGMP regulations require manufacturers to ensure that products are free of contamination by objectionable organisms, and that appropriate microbiological testing is conducted.

BioLumix Rapid Microbiology offers a high degree of automation, significant reduction in time to results, reduced staff involvement, and faster product release. . .  all which impact key “operational profit drivers,” such as:

  • Savings as a result of early detection of contamination
  • Lower cost of inventory
  • Increase capacity of existing factory and lab
  • Reduce cost of storage
  • Lower cost of test related overhead
  • Savings on cost of capital
  • Potential improvement in account receivables

 

Contact Us TODAY To Learn More About Our FREE DEMO PROGRAM!

Rapid Microbiological Method or Conventional Method? What Should You Use?

In the get-it-done-yesterday environment companies are finding that the traditional microbiological methodologies and especially sending microbiological samples to outside labs cost them time, money and opportunities1.  Internalizing the microbiology testing and especially adopting rapid microbiological methods (RMM) can significantly speed up the time to results from 7-10 days to 24-48 hours.  The time saved creates opportunities for faster response to contamination, quicker product release, faster delivery of product to the marketplace, reduced warehouse space, and enhanced product quality.  Advantages of RMM can include: Greater accuracy, better sensitivity, increased sample throughput, automated data capturing allowing easier data handling, and reduced cost for product release.

However, like any other investment it competes for company resources.  Therefore, there is a need to calculate the financial benefits of the investment in RMM.

Dr. M. Miller, an authority on RMM, has written extensively on this topic and suggests that before adopting a new RMM or internalizing Microbiology the key steps required include2, 3, 4:

  1. Review of existing technologies
  2. Understand the technical and financial benefits of RMM
  3. Develop the business case for RMM

This will include the use of financial models that can compare the overall costs associated with the current microbiology method with the costs and savings associated with the purchase, qualification, and implementation of the RMM

Return on Investment (ROI)

ROI is the ratio of money gained or lost on an investment relative to the amount of money invested.  According to Dr. Miller3 for RMMs, the cost of performing the conventional method (CM) is compared with the cost (and savings) of using the new method. The information is reported as a percentage and usually represents an annual or annualized rate of return. The ROI is calculated using the following formula4:

CM costs can include:  cost of consumable; reagents and supplies; sample preparation time; data management documentation and record retention time; as well as cost of labor and overhead.

Potential investment in RMM can include:  Capital cost; and validation cost.

Potential cost savings of RMM can include:  Reduced time for product release; Lower headcount; lower re-processing fees; reduction in plant downtime; increased production yields; reduced raw materials, in-process and finished products inventory holding; reduction in back orders; increased production flexibility; and better protection of company image.

Payback Period (PP)

The PP is the time required for the return on an investment to “repay” the sum of the original investment. In the context of implementing an RMM, this would be the time (usually in years) required to realize sufficient cost savings to pay for the initial investment of the RMM capital equipment as well as for qualification and implementation activities3, 4.

Requirements from RMM

While Rapid Microbiological Methods (RMM) offer high degree of automation, significant reduction in time to results, faster product release, ability to employ non-microbiologists to operate the system, and improved control; there are three basic objectives that must be meet:

  1. Comply with FDA and cGMP regulations
  2. The RMM must be validated against the standard USP methodology using a protocol similar to USP <1223>.
  3. Ensure a swift return on investment.

Additionally, the ideal system should be capable of:

  1. Performing all the microbiological assays required to be performed by lab on a single platform.
  2. The technology should eliminate or at least minimize any product interference.
  3. Allow for a paperless microbiology laboratory-allowing the laboratory to operate without handwritten data entries
  4. Automate the system reporting
  5. Real-time communication to locations outside the lab to provide early warning of contamination

Required Commitment from RMM Vendors

Validation:

To make the transition to a rapid method the vendor should help in the system validation to make the transition to the new system smooth and “painless”. It should include Installation Qualification (IQ); Operational Qualification (OQ), and help with the Performance Qualification (PQ). PQ is the most extensive portion of the validation and sometimes companies considering RMM are deterred by the amount of work required for validation. Vendors can generated most of the data and submit it to the FDA in a form of a DMF.  The same information can be supplied to new users together with unique data pertaining to their products.

Software:

The software must be compliant with 21 CFR Part 11.  21 CFR Part 11 regulations are established requirements to ensure that electronic records and electronic signatures are trustworthy, reliable and generally equivalent substitutes for paper records and traditional handwritten signatures. Any instrument system containing software must be compliant with this regulation.

Technical Support:

Instruments suppliers should guaranty live technical service that is fast, knowledgeable, and readily available.

The BioLumix system is an example of a system that fulfills the requirements listed above.  Its straightforward streamlined design offers rapid accurate results leading to reduced material-holding time for faster product release.  Early warning of contaminated samples as well as sample release information could be automatically communicated through your intranet, significantly improving your company’s efficiencies.

To evaluate the value proposition of RMM systems BioLumix offers a free assessment of your specific ROI and Payback Period.  This will help you determine whether there are sufficient cost benefits of adopting a RMM system.  Past ROI calculations demonstrated that in many situations the ROI obtained showed that a RMM, like the BioLumix system, improved the company’s bottom line and satisfied the financial expectations of site management.

References

  1. 2009. Gadal, P.; Yvon, P. Rapid Microbio ROI – Calculating scientific benefits as return on investment dollars. Pharmaceutical Formulation & Quality. 11(3): 44-47.
  2. 2009. Miller, M.J. Breaking the rapid microbiological method financial barrier: A case study in RMM return on investment and economic justification. BioPharm International. 22(9): 44-53.
  3. 2009. Miller, M.J. Ensuring ROI from your RMM. Pharmaceutical Manufacturing. 8(6): 32-35.
  4. http://rapidmicromethods.com/files/roi.html
  5. USP <1223> Validation of Alternative Microbiological Methods.

Ruth Eden, PhD

President

BioLumix. Inc.